Role of Leukotrienes and Adenosine in Hyperpnea-induced B... | NCT00710255

Studies
Role of Leukotrienes and Adenosine in Hyperpnea-induced Bronchospasm

NCT00710255

Sponsor

University of Vermont

Status

Completed

Last Update Posted

Oct 31, 2016Estimated

Enrollment

8Actual

Phase

Not provided

Conditions

Asthma, Exercise Induced

Interventions

Hyperpnea challenge

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Merck IISP 32710

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Mar 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Jul 2, 2008

First Submission Date that Met QC Criteria

Jul 3, 2008

First Posted Date

Jul 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2016

Last Update Posted Date

Oct 31, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This research is being conducted to help us better understand what causes exercise induced asthma. The investigators hypothesize that two types of chemicals, cysteinyl leukotrienes and adenosine, play an important role. The investigators will be measuring these chemicals in the exhaled breath of volunteers with exercise induced asthma as they undergo a test to mimic exercise induced asthma. The investigators will determine how the levels of these chemicals change in association with how lung function changes before, during and after an episode of exercise induced asthma.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Asthmatics		Asthmatics with exercise induced bronchospasm	Procedure: Hyperpnea challenge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyperpnea challenge	Procedure	5 minutes of dry air hyperpnea to induce bronchospasm	Asthmatics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in level of cystLTs and adenosine		Before and after hyperpnea challenge

Secondary Outcomes

Measure	Description	Time Frame
Change in pH of EBC and change in pulmonary function		Before and after hyperpnea challenge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Physician diagnosed asthma
Age 12-75 yrs
FEV1 > 70% predicted
HIB response > 10 %
No smoking last 6 mo and < 10 pack yrs
No URI last 4 weeks
No asthma exacerbation last 4 weks
Able to withhold SABA > 8 hrs and LABA > 24 hrs

Exclusion Criteria:

Other lung disease
Cardiac disease or other condition that would preclude safe participation, on theophylline or leukotriene modifiers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Asthmatics with exercise induced bronchospasm

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David A. Kaminsky, MD	University of Vermont	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vermont Lung Center		Colchester	Vermont	05446	United States

Condition Browse Module

MeSH Terms

ID	Term
D001250	Asthma, Exercise-Induced
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity
D000092202	Exercise-Induced Allergies

Browse Leaves

Not provided

Browse Branches

Not provided